Aurobindo Pharma Ltd received the tentative NDA approval for fixed drug combination product containing Lamivudine150 mg+2idovudine300 mg tablets co packaged with Abacavir 300 mg tablets (NDA) used in the treatment of HIV-1 infection. The three drugs are now available in one single pack.
This fixed drug combination pack comprising two-nucleoside reverse transcriptase inhibitor (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTIs) is used in several HIV patients. In many parts of the world, the regimen containing Lamivudine, Zidovudine and Abacavir is popular. Such therapy enhances the convenience and compliance, is cost effective and reduces the threat of resistance due to missed doses. With the approval of such a combination by US FDA, several patients under PEPFAR programme will be immensely benefited.
This is the first NDA generic approval in the world for a three-drug combination co pack. The company is vertically integrated in the APIs and formulation for this product. These three drugs command over six hundred million-dollar market worldwide and the usage of the drugs is growing due to the outstanding commitment of the US Govt. in particular and the WHO to rehabilitate HIV patients. With this approval, the ARV product portfolio of the company has increased to 18 including 3 NDA approvals